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RecruitingNCT07385235Updated Feb 11, 2026

Compare and Evaluate the Safety and PK Data of a Single Dose Administration of 'AD-115A' or 'AD-1151'

A Phase 1 interventional study of AD-115A, AD-1151 in Gastric Ulcer, sponsored by Addpharma Inc.. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-02-11.

Sponsored by Addpharma Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Jan 2026; still recruiting 8 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

The study compare and evaluate the safety and pharmacokinetic characteristics of a single dose administration of 'AD-115A' or 'AD-1151' in healthy adults.

Read the detailed description

A randomized, open-label, single-dose, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the administration of AD-115A and the administration of AD-1151 for healthy subjects in fasting state

02

Conditions studied

  • Gastric Ulcer

Browse trials for

03

In context

Stomach Ulcer

112 studies on the registry are indexed under Stomach Ulcer; 13 are open to participants now.

This study's planned enrollment of 46 is below the median of 265 across 86 interventional studies indexed under Stomach Ulcer.

Browse Stomach Ulcer studies →

Lead sponsor

Addpharma Inc. is the lead sponsor of 56 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • The Age equal to or greater than 19 in healthy volunteers at the time of screening visit
  • Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit

Exclusion criteria

Exclusion Criteria:

  • Individuals who have taken drugs that induce (e.g., barbiturates) or inhibit drug-metabolizing enzymes within 30 days prior to the start of the study (first dosing day), or have taken drugs that may affect this study within 10 days prior to the start of the study (first dosing day)
  • Other exclusions applied
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
46 participants (estimated)

Study arms

  • Experimental
    Sequence A

    Period 1 : Reference Drug(Rebanex Tab), Period 2 : Test Drug(Revaprazan sulfate) Single-dose oral administration of AD-115A (200 mg tablet) in Period 1, followed by single-dose oral administration of AD-1151 (200 mg tablet) in Period 2.

    Drug: AD-115A, AD-1151

  • Experimental
    Sequence B

    Period 1 : Test Drug(Revaprazan sulfate), Period 2 : Reference Drug(Rebanex Tab) Single-dose oral administration of AD-115A (200 mg tablet) in Period 1, followed by single-dose oral administration of AD-1151 (200 mg tablet) in Period 2.

    Drug: AD-115A, AD-1151

Interventions

  • DrugAD-115A, AD-1151

    Single-dose oral administration of AD-115A or AD-1151 (200 mg tablet), according to randomized sequence.

06

What researchers measure

Primary outcomes

  1. Maximum concentration of drug in plasma (Cmax)

    Cmax of AD-115A

    Time frame: pre-dose to 24 hours

  2. Area under the plasma concentration-time curve during dosing interval (AUCt)

    AUCt of AD-115A

    Time frame: pre-dose to 24 hours

07

Study locations

1 of 1 sites recruiting
  • H PLUS YANGJI HOSPITAL, Seoul
    Seoul, South Korea
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07385235
Lead sponsor
Addpharma Inc.
Responsible party
Sponsor
First posted
Feb 4, 2026
Start date
Jan 27, 2026
Primary completion
Mar 7, 2026 (estimated)
Completion
Mar 16, 2026 (estimated)
Last update
Feb 11, 2026

Study contacts

JaeHun Jung
Contact
jhjung@addpharma.co.kr
+82-31-891-5683

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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